CHILD DEVELOPMENT IN RELATION TO EARLY OTITIS MEDIA

描述（改编自研究者摘要）：本应用程序是 继续支持1991年6月开始的一项研究， 目的是确定是否持续性中耳炎与渗出液 (OME)在生命的前3年， 言语、语言、认知或心理社会发展，如果是，是否 及时放置鼓膜造口管（TTP）可防止或减少 损伤 次要目标是确定是否增加 在进行TTP之前需要OME的持续时间导致操作减少 或改变长期耳科或听力学结果，并绘制 中耳炎（OM）的发生和病程以及相关的听力损失， 幼儿，尽可能少地通过手术干预扭曲。 先前关于OM与后期发育障碍的研究 他们的行为是不确定的，矛盾的，不合适的，因为他们的行为是不正确的。 联想设计，以解决因果关系的问题。 共计6400人 8<2 mo from 2 hospitals and 6 private pediatric practices will have been enrolled over a 54-month period ending Dec 1995. Their middle-ear status is monitored monthly. Those who develop acute OM or persistent OME receive antimicrobials. In those with long >周龄婴儿 每月安排测听。 3岁以下儿童， 关于持久OME的特定标准是，在同意的情况下， 随机分配至即刻（“早期TTP”）或在规定的 如果OME仍然存在，则延长时间（“晚期TTP”）。 高OME 人口被分为2组，可以假设他们具有等同的 发展潜力：早期TTP群体，其中大多数人相对来说变得 无OM，以及TTP晚期组，其中大多数人继续患有OM， 时期 如果后期组随后有较不利的发展 结果，持续的OM可能是因果关系。 发展是 通过父母对所有1岁和2岁受试者进行主观评估 问卷调查 对言语、语言、认知和 在3岁、4岁和6岁时，对所有儿童进行心理社会发展评估。 符合随机化标准的受试者和其他受试者样本 代表了OME的经验。 试验结果分析 这些组将能够确定关联是否 短期或长期，存在于持续早期OME和后期OME之间 发展障碍;若有，两者是否有因果关系;及 快速TTP是否能有效预防或减轻此类损伤。 截至1995年10月5日，6030名儿童已登记，376名儿童符合 随机化标准，292人被随机分配到早期或 晚期TTP组。 迄今为止的分析提供了关于 OM的流行病学，鼓室压测试的诊断预测价值， 以及OME累积持续时间与语言之间的相关性， 1岁和2岁时的行为 如果继续下去，这项研究将提供新的 使更合理的循证管理成为可能的知识 婴儿和幼儿的OM，从而使儿童受益， 对儿童保健做法和费用产生重大影响。

DESCRIPTION (Adapted from the Investigator's Abstract): This application is for continuing support of a study, initiated in June 1991, whose main objectives are to determine whether persistent otitis media with effusion (OME) during the first 3 years of life results in lasting impairments of speech, language, cognitive, or psychosocial development, and if so, whether prompt tympanostomy-tube placement (TTP) prevents or lessens the impairments. Secondary objectives are to determine whether increasing the duration of OME required before undertaking TTP results in fewer operations or in altered long-term otologic or audiologic outcomes, and to chart the occurrence and course of otitis media (OM) and associated hearing loss in young children, distorted as little as possible by surgical interventions. Previous studies of OM in relation to later developmental impairment have been inconclusive and contradictory, and unsuited, because of their associational design, to address the issue of causality. A total of 6400 well infants aged <2 mo from 2 hospitals and 6 private pediatric practices will have been enrolled over a 54-month period ending Dec 1995. Their middle-ear status is monitored monthly. Those who develop acute OM or persistent OME receive antimicrobials. In those with long > 8 wk duration audiometry is scheduled monthly. Up to age 3 yr, children who reach specified criteria regarding persistent OME are, subject to consent, randomized to receive TTP either promptly ("early-TTP") or after a defined extended period if OME remains present ("late-TTP"). Thus a high-OME population is divided into 2 groups who can be assumed to have equivalent developmental potential: an early-TTP group most of whom become relatively OM-free, and a late-TTP group most of whom continue to have OM for varying periods. If the late group subsequently has less favorable developmental outcomes, persisting OM will presumably have been causal. Development is assessed subjectively in all subjects at ages 1 and 2 yr via parent questionnaires. Formal tests of speech, language, cognition, and psychosocial development are administered at ages 3, 4, and 6 yr to all subjects who had met randomization criteria and to a sample of others representing a spectrum of OME experience. Analyses of test results in these groups will enable determinations of whether associations, either short- or long-term, exist between persistent early OME and later developmental impairments; if so, whether the associations are causal; and whether prompt TTP is effective in preventing or lessening such impairments. As of Oct 5, 1995, 6030 children had been enrolled, 376 had met randomization criteria, and 292 had been randomly assigned to early- or late-TTP groups. Analyses to date have provided new information about the epidemiology of OM, about the diagnostic predictive value of tympanometry, and about correlations between cumulative OME duration and language and behavior at ages 1 and 2 yr. If continued, this study will provide new knowledge that will make possible more rational, evidence-based management of OM in infants and young children, and thereby benefit children and substantially influence child health care practices and costs.